JP2003521272A - Bidirectional pressure maintenance device and method - Google Patents

Abstract

(57) Abstract: Provided is a method for using a bidirectional pressure maintaining device and a pressure generating device for performing pressure therapy on lung tissue of a subject, wherein the bidirectional device connected to the pressure generating device interacts with the subject. Then, for example, the therapeutic effect of the pressure holding device is monitored. The interactive device includes an output device that provides the subject with first information, an input device that provides the subject with second information based on the first information, and a first information and a second information based on the input device. And a control device that controls the operation of the output device that indicates the aggregation.

Description

Detailed Description of the Invention

[0001]

BACKGROUND OF THE INVENTION

1. TECHNICAL FIELD The present invention relates to a bidirectional pressure maintenance device and a method of using the same to treat respiratory disorders,
In particular, when treating a respiratory disorder in a patient, the subject responds to a question or performs an operation that confirms the effect of pressure treatment, thereby bidirectional function (interaction) with the subject (patient).
The present invention relates to a device for performing pressure treatment on a subject by performing the above-mentioned procedure.

2. 2. Description of Related Art There are a number of diseases that are diagnosed and / or monitored using questions or cognitive tests performed on a subject. Generally, the subject has a sleep disorder, such as obstructive sleep apnea (OS).
The method for determining whether the condition is A) is to measure the sleep characteristics of the subject. Also, the subject's sleep properties and / or changes in sleep properties can be used to determine the extent of the disorder and / or monitor changes in the subject's condition. A conventional technique for measuring the sleep characteristics of a subject is Epworth SleepiScore (Epworth SleepiScore).
ness Score: ESS). ESS is determined based on retrospective reports by sleep-testing subjects in a variety of situations commonly encountered in normal daily life.
The retrospective report is explained by the subject through a series of questions. The subject's response to the above questions is ESS-determined and tabulated to assess the subject's sleep quality.

Currently, Ipworth inspections are commonly processed on paper. For this reason, the form for the writing test is physically supplied to the subject, and the form in which the subject answers the question must be collected thereafter. The test administrator manually creates the response from the subject (or
Computer generated) and calculates ESS based on subject response.
Distribution, collection, time stamping, table making, scoring, which were required by conventional inspection technology,
Management requirements such as storage and storage place a heavy burden on the inspection provider. This burden increases with the number of tests performed on each subject and the number of subjects performing the test. In general, the same subject will perform multiple Epworth tests throughout the procedure to monitor therapeutic efficacy. For example, follow-up of a subject to determine the effectiveness of treatment for sleep disorders or respiratory disorders is a relatively expensive and cumbersome method.

Another prior art technique for measuring a subject's response time and cognitive agility, which is generally considered to be indicative of the subject's sleep behavior, is the Vigilance test. In the arousal test, generally, the subject is required to respond to the display through an input device connected to the personal computer, and the test result is processed by the personal computer. The response time of the responding subject and / or the response accuracy to the display is measured and stored to determine the subject's level of agility. For example, the recognition target on the personal computer display is shown to the subject, and the reaction time and the recognition accuracy of the subject for identifying the target are measured.

Since this test is usually processed by a personal computer, it must be processed only by a device at the location of a properly programmed personal computer, requiring the subject to move to the location where the personal computer is located. Alternatively, the subject is given a properly programmed personal computer. However, the latter increases the cost of providing the subject with a personal computer and requires the subject to be trained to use this type of device, which is relatively complex. It is recognized that any option of performing a wakefulness test places a significant burden on both the subject or the test administrator.

[0006]

DISCLOSURE OF THE INVENTION

SUMMARY OF THE INVENTION It is therefore an object of the present invention to provide an apparatus and method for performing pressure maintenance therapy and managing question or cognitive tests for a subject to overcome the shortcomings of the prior art.
In an embodiment according to the present invention, the object is achieved by providing a bidirectional pressure maintaining device comprising a pressure generating device for applying pressure treatment to the lung tissue of a subject and a bidirectional device connected to the pressure generating device. . The interactive device includes an output device that supplies information such as a question or a code to the subject, and an input device that receives information from the subject such as a response to the question or a response to the displayed code. In addition, the interactive device includes a control device that controls the operations of the output device and the input device, correctly presents the question information to the subject, and collects the responses provided by the subject through the input device.

This single device combines the subject treatment function of the pressure holding device with the subject evaluation function of the question or cognitive test processed by the interactive device. Since the test is performed using the same device given to the subject who treats the disorder, the bifunctional device reduces the administrative burden and cost of providing a question or cognitive test and is already at a high pressure. Using the processing function existing in the holding device, each function of the inspection method and the collection, calculation, storage and communication of the result can be automatically executed. Furthermore, because the test function is built into the same device that is given to the subject who treats the condition monitored by the test, the subject is familiar with the device that manages the test and at the same time is motivated to perform the test correctly and enthusiastically. As a result, the test function can be exerted with less training than in the case where the test subject is executed by a completely different test apparatus.

In a further embodiment according to the invention, the control device has an additional function of computing a result indicative of a subject's state, for example calculating a score indicative of the subject's condition, such as ESS indicative of the subject's sleep behavior. Demonstrate. In other embodiments, the two-way pressure maintenance device can store a number of different types of tests, results of repeated tests, results provided by the subject during the test, and information identifying the time / date of the test. A memory device is thus provided. Further, in other embodiments, data communication between the interactive device and a remote storage device is enabled, new test data is provided to the interactive pressure maintenance device, and / or collected at the interactive pressure maintenance device. A communication device is provided that sends information to, for example, a remote storage device.

[0009] Yet another object of the present invention is to provide a method of treatment and monitoring of treatment for respiratory disorders without the disadvantages of the prior art. This object is achieved by a method that includes the following steps. (1) provide the subject with pressure treatment and provide a device with interactive function, (2) provide the subject with information, such as a question or code, and (3) through the device, information from the subject, such as a question. To get a response to or to the displayed code. In a further embodiment of the invention said method also comprises
Remember different information provided to the subject, similar to the results of repeated testing of the subject,
Memorizing the results provided by the subject based on the results. In yet another embodiment, a remote storage device is communicated to exchange information, such as different or additional test information provided to the subject and, based on the results, the subject-provided results with the bidirectional pressure maintenance device. Including the process of doing.

By the following description with reference to the accompanying drawings, in which reference numerals indicate corresponding parts in the drawings, the claims and all constituent parts of the specification, the above and other objects, features and characteristics of the present invention, The operation method and function of related elements, the combination of parts, and the manufacturing economy will become clear. However, the drawings are only for purposes of illustration and description and are not intended to limit the scope of the invention.

[0011]

[Detailed Description of Preferred Embodiments]

1 and 2 show a first embodiment of a bidirectional pressure maintenance device 30 according to the principles of the present invention. The bidirectional pressure maintaining device 30 includes a pressure generating device 32 and a bidirectional device 34.
Equipped with two devices. The pressure generator 32 performs positive pressure treatment on a subject (patient). For example, the pressure generator 32 may be a continuous positive airway pressure (CPAP), which is a variable pressure therapy in which the pressure supplied to the subject is changed by inspiration and expiration, or is changed according to the disorder treatment needs of the subject. ) Treat.

The pressure generator 32 generally comprises a pressure generator 36 and optionally a pressure controller 38. In a minimum combined pressure treatment device such as CPAP, the pressure supplied to the subject is kept constant or a predetermined pressure fluctuation (profile) regardless of the condition of the subject.
In general, the pressure control device 38 is not necessary because Variable pressure therapy, such as two-level therapy, as described in U.S. Pat. Proportional Positive Airway Pressure of US Pat. Nos. 5,535,738 and 5,794,615 in the name of Estes et al.
PPAP), as well as US Pat.
Proportional Assist Ventilat of 5,044,362 and 5,170,830
In ion: also known as PAV), the pressure control device 38 controls the pressure supplied to the subject.
Generally, controlling the output of the pressure generator, for example the speed of the blower of the blower pressure generator, or adjusting the pressure in the subject delivery line 40 that supplies gas to the subject through a single valve or series of valves, The pressure control device 38 controls the pressure on the subject.

The variable pressure treatment device includes a sensor (not shown) that detects the condition of the subject and controls the pressure supplied to the subject based on the detected condition. For example, when changing the pressure supplied to the subject in response to the breathing cycle of the subject, a sensor such as a flow sensor or a pressure sensor connected to the respiratory conduit 40 may change from an inspiratory effect to an expiratory effect and vice versa. The change of the respiratory cycle which is the change of is detected. The pressure control device 38 controls the pressure / flow rate supplied to the subject so as to change depending on the inspiration or expiration of the subject.

The sensor monitors the subject's disability as the pressure applied to the subject is varied in response to changes required to treat the subject's disorder. For example, a flow sensor and / or a pressure sensor provided in the breathing conduit detects an abnormality in the gas flow moving forward and backward with respect to the subject, or the microphone or the pressure sensor detects a snoring, and both the abnormality and the snoring of the gas flow are detected. , Generally indicates a subject's airway disorder. The pressure control device 38 controls the pressure supplied to the subject on the basis of the feedback signal from the sensor to supply sufficient pressure, for example, to mitigate abnormal disorders such as airway obstruction, and immediately once the abnormal disorders decrease. Reduce pressure. US Pat. No. 5,203,343 to Azze et al., Which forms part of this specification.
U.S. Pat. No. 5,458,137 and Limmer et al., U.S. Pat. No. 5,645,053, show examples of pressure-holding devices that change the pressure on a subject in response to changes required to treat a disorder.

In the illustrated embodiment, controller 42 controls the operation of pressure generator 32 by controlling pressure generator 36 and pressure controller 38. In one embodiment of the invention,
The control device 42 controls the pressure supplied to the subject as described above in cooperation with the pressure control device 38 by the subject (patient) monitoring function. However, the controller 42 may perform other functions such as monitoring use of the pressure generator (subject adaptability), performing diagnostic routines and providing error / warning indications. Also, for example, a nose mask,
A subject interface device 44, which comprises a nose / mouth mask, full face mask, nasal cannula, tracheal tube, or any other suitable device, connects the respiratory tract 40 to the subject.

The bidirectional device 34 provides a bidirectional function that enhances the pressure therapy function of the pressure generator 32. The interactive device 34 asks the subject about his / her condition and / or causes the subject to perform an operation of displaying the condition of the subject. In the illustrated embodiment, the bidirectional device 34 shares a common housing 46 with the pressure generator 32. The device, which includes a system for performing pressure therapy and which treats disorders in subjects, is advantageous in that it can manage questions or cognitive tests,
Accordingly, it is possible to avoid the need for the test subject to move to the test position or for the test administrator to manually distribute the test sheet for each test subject or each time the test subject receives the test. Also, because this combination utilizes processing functions commonly included in current pressure holding devices, the cost of introducing or modifying bidirectional functions in current pressure holding devices is minimized.

The interactive device 34 comprises an output device 48, which constitutes a display in the illustrated embodiment, and an input device 50, which are both connected to the control device 42. Display 48
Provides the user with a question, code, image, or other visual representation. Display 48
Is preferably a display such as a liquid crystal display (LCD) or a cathode ray tube. However, it will be apparent that other output devices may be used with the present invention. For example, the output device is a voice or Braille device for the visually impaired, a printer, or a device that outputs user-perceptible type information from the interactive device. The input device 50 is
Information is supplied from the user to the controller. The input device 50 is preferably a device such as a keyboard, a keypad, a touch screen device, a voice recognition device, a stylus, a mouse, a trackball, a button, a knob, a card reading device and / or a switch that achieves this function. In the illustrated embodiment, the knob and keypad 50 is used as an input device.

The control device 42 is preferably a device that performs the above-mentioned function relating to the pressure generating device 32 and the input / output function of the bidirectional device 34. However, the two functions are also performed by a separate control device connected to each of the pressure generating and bidirectional devices 32 and 34. The controller 42 also includes a memory of suitable capacity to store the information necessary to perform the functions described above, eg, sufficient memory to store a display to the user and its response.

In the illustrated embodiment, the bidirectional device 34 also comprises an optional communication device 52 and additional memory 54 that is not required to perform the interaction of the bidirectional device 34. Communication device 52
Provides the interactive device 34 with a function of transmitting and / or receiving information to / from an external device. Furthermore, the communication device 52 controls the operating parameters of the treatment device from an external device,
Monitor or control and monitor. The communication device 52 is, for example, a modem, RS-232, ISD.
A data transfer device that transmits N or other connection device or information to the control device and outputs the information from the control device.

The memory 54 functions as an expansion memory that supplements the memory of the control device 42. Memory 54
Stores, for example, additional tests performed on the subject, expanded capacity of input results from the subject, and / or scores associated with the results provided by the subject. Communication device 52
On request, or when the test results are outside the prescribed limit criteria, this information is downloaded regularly. For example, when the subject's condition shows a dramatically worsened test result, the test and alert results are automatically sent by the bidirectional pressure maintenance device to one or more remote storage devices, if desired. .

Further, in the present invention, the functions of the communication device 52 and the memory 54 can be incorporated in a single device. For example, a "smart card" of memory, commands, data or combinations thereof can be used in connection with controller 42. This type of card is preferably capable of being inserted into the receiving port of the housing containing the control device 42 and storing data, for example test results stored in the control device and adaptability data relating to the use of the treatment device in the card. The card containing the data is physically removed from the housing and, if desired, mailed to a management center where the data is collected. Also, the control device
The smart card can be programmed by commands or instructions downloaded to 42. The supervising caregiver simply inputs an appropriate command to change the parameter on the smart card, and the operating pressure of the test or treatment device to be applied to the subject, for example, CPAP, Inspiratory Positive Airway Pr
essure: IPAP) or Expiratory Positive Airway Pressure
: EPAP) can be changed.

In the present invention, as necessary to meet the specific requirements of the subject, inspection questions,
A flexible test can be performed on the subject that can be adjusted in response to changes in the patient, as well as coordinating the information or the subject's termination or performance of the operation. In addition, in the latest and automated form that minimizes the burden on the inspection manager when necessary, the actual (
Collection, processing, analysis, tabulation and distribution of raw test results, or calculation, processing and distribution of information determined based on test (test score) results can be stored, analyzed and distributed. Moreover, as the subject's condition changes, the operating parameters of the treatment device can be controlled and modified to suit the particular needs of the subject.

Although FIG. 1 illustrates the same housing in which the pressure generating device 32 and the bidirectional device 34 are located, in a further embodiment of the invention the two devices are not provided in the same housing and Device 34 cooperates with pressure generator 32 to share common elements. For example, the display 48 and / or the input device 50 may be a portable size LCD (liquid crystal display) device or the like connected to the control device of the bidirectional pressure maintenance device 30 housed in the housing either wirelessly or by wire. It is a remote means. In addition, other components of the interactive device, such as communication device 52 and memory 54, may be provided on a device external to housing 46.

FIG. 3 is a block diagram of a communication network 60 including the bidirectional pressure maintaining device 30 of the present invention. In the illustrated network, through communication links 62 and 64 and communication system 66, a number of two-way pressure maintenance devices 30 include one or more remote storage devices.
Communicate with 68. Wired or wireless communication means 62 and 64 may be used as long as they send and receive information to and from the bidirectional pressure maintenance device 30 and / or remote storage devices. In the present invention,
An amplifier, a converter and an adapter can be provided when it is necessary to easily perform data transmission on the communication means. The communication device 66 is a communication network that transmits data from one storage device to the other storage device. For example, the communication device 66 may be a conventional telephone or computer network having a two-way pressure maintenance device 30 in communication with a remote storage device 68 through a modem, satellite based device, fiber optic / optical device, microwave device or combination thereof. Can be used.

Remote storage device 68 may be any device capable of communicating with bidirectional pressure maintenance device 30. The remote storage device is typically a computer located at the location of the healthcare provider and / or examination administrator. In an exemplary embodiment of the invention, a user at a remote storage device downloads data from a base station of communication device 66 that collects data from the interactive pressure maintenance device and / or from the interactive pressure maintenance device 30, This information can be used to monitor the condition of the subject. For example, at each day on time, either by programming the bidirectional pressure maintenance device or by the automatic interrogation function of the remote storage device,
The user of the bi-directional pressure maintenance device can manually or automatically download this data. Further, the data can be automatically downloaded by the bidirectional pressure maintenance device when the test result of the subject is outside a predetermined threshold.

FIG. 4 is a flow chart illustrating one embodiment of a method performed by a bidirectional pressure maintenance device. The method starts at step 70, but can be started from various starting points. For example, a subject using the bidirectional pressure maintenance device 30 may perform the examination periodically, or a user of a remote storage device may use the bidirectional pressure maintenance device 30 to initiate the examination as needed or periodically. It can be programmed to request that the test be performed manually. Once the test is initiated, the test using the interactive system 34 as described above is performed on the subject at step 72. In an exemplary embodiment of the invention, the Epworth and / or wakefulness test is performed to determine the sleep quality of the subject. During the examination process of step 72, the subject receives and responds to questions or other indications.

Responses to query results and / or displays, such as reaction time and recognition accuracy, are aggregated at step 74. Further, in the present invention, when the inspection is performed, data indicating either the absolute time of the inspection or the relative time with respect to the reference is stored. Steps 72 and 74 are repeated as needed until the test is complete. The test results entered by the subject using the input device are tabulated and, if necessary, the test score is determined at step 76. Depending on the desired operation of the interactive device, the test score, test results and / or other data, such as time spent in the test or information regarding the test, may be stored at step 78 in controller 42 and / or memory 54, and thereafter. , Read and / or send to a remote storage device in step 80, or the processing in steps 78 and 80 is performed,
Immediately after the inspection is completed, the inspection result is transmitted to the remote storage device 68 or the remote storage device such as the processing device of the communication device 66. The inspection procedure ends at step 82. Information on the time spent in the test assists in recording the progress of the treatment and is particularly useful when compared to the test results of serial tests. The inspection information includes, for example, data identifying performed inspections that indicate whether they are different types or levels of inspections. For example, during treatment of a disorder, the subject may perform a series of tests over a period of time when the disorder increases or does not increase.
The data output according to the present invention includes information indicating which test of the serial test was performed on the subject.

The present invention comprises an apparatus that performs two functions. (1) For example, a pressure holding device that performs OSA is used to perform treatment on a subject and correct an abnormality received from the subject. (2)
The interactive feature allows a caregiver to regularly monitor the effectiveness of treatment by treating the subject with the same device and performing a test on the subject to measure the condition of the subject. in this way,
The present invention, which minimizes the burden on patients, caregivers and study managers, can increase the utility of conventional treatment devices, reduce costs and improve follow-up of subject treatment.

Although the presently most practical and preferred embodiments have been illustrated and described in detail, the above description is merely for the convenience of description, and the present invention is not limited to the disclosed embodiments and the present invention is not limited thereto. The invention is intended to fall within the scope of the claims and encompass modifications and equivalent devices of the scope of the claims.

[Brief description of drawings]

FIG. 1 is a perspective view of a bidirectional pressure maintaining device according to an embodiment of the present invention.

FIG. 2 is a block diagram of the bidirectional pressure maintenance device of FIG.

FIG. 3 is a block diagram of a communication network including a bidirectional pressure maintaining device.

FIG. 4 is a flow chart illustrating one embodiment of a method performed by a bidirectional pressure maintenance device.

[Explanation of symbols]

30 ・ ・ Pressure holding device, 32 ・ ・ Pressure generator, 34 ・ ・ Bidirectional device, 36 ・ ・
Pressure generator, 42 ... Control device, 48 ... Display, 50 ... Input device,
60 ... Communication network, 66 ... Communication device, 68 ... Remote storage device,

─────────────────────────────────────────────────── ─── Continued front page    (81) Designated countries EP (AT, BE, CH, CY, DE, DK, ES, FI, FR, GB, GR, IE, I T, LU, MC, NL, PT, SE), AU, CA, J P

Claims (30)

[Claims] 1. A pressure generating device for performing pressure treatment on lung tissue of a subject, and (b) a bidirectional device connected to the pressure generating device, wherein the bidirectional device provides the subject with first information. An output device for supplying the first information, an input device for receiving the second information supplied from the subject based on the first information, and an aggregate of the first information and the second information from the input device are displayed on the output device. A bidirectional pressure maintenance device, comprising: a control device that controls the operation of the output device. 2. The bidirectional pressure maintenance device according to claim 1, wherein the first information includes a test result for measuring the effect of the pressure treatment. 3. The bidirectional pressure maintenance device according to claim 2, wherein the test result is a series of questions for measuring a subject's daytime sleep tendency. 4. The bidirectional pressure maintenance device according to claim 2, wherein the test measures at least one of the response time and the cognitive agility of the subject. 5. The bidirectional pressure maintenance device according to claim 1, wherein the control device analyzes the second information and determines the measurement result of the characteristic of the subject affected by the pressure treatment based on the analysis. 6. The bidirectional pressure maintenance device according to claim 5, wherein the bidirectional device includes a memory that stores at least one of the second information and the measurement result. 7. The bidirectional pressure maintenance device of claim 5, wherein the bidirectional device also comprises a communication device for communicating at least one of the first information, the second information and the measurement result with a remote storage device. 8. A pressure generator having a pressure generator for receiving gas from at least one gas source and supplying gas to a subject at high pressure, and a first end operatively connected to the pressure generator. 7. A respiratory circuit and a subject interface device operatively connected to the second end of the respiratory circuit.
A two-way pressure maintenance device as described in. 9. The bidirectional pressure maintenance device according to claim 1, wherein the pressure generating device and the bidirectional device are connected to each other by being operatively connected to a common housing. 10. The bidirectional pressure maintenance device according to claim 1, wherein the bidirectional device further comprises a memory for storing the first information and the second information. 11. The bidirectional pressure maintenance device of claim 1, wherein the bidirectional device also collects third information for at least one of the first information and the second information. 12. The third information is (1) (a) an inspection management time indicating a time when the first information is supplied to the user, and (b) an inspection indicating a time when the second information is received from the user. The bidirectional pressure maintenance device according to claim 11, comprising at least one of time information for identifying at least one of the end times and (2) identification information for identifying the first information supplied to the user. 13. Pressure generating means for performing pressure treatment on lung tissue of a subject, and first information provided to the subject and connected to the pressure generating means, and second information based on the first information is received from the subject. A bidirectional pressure maintaining device comprising: a subject bidirectional means. 14. The bidirectional pressure maintenance device according to claim 13, wherein the first information includes a test result for measuring the effect of the pressure treatment. 15. The two-way pressure maintenance device according to claim 14, wherein the test is a series of questions that measure a subject's daytime sleep tendency. 16. The bidirectional pressure maintenance device according to claim 14, wherein the test measures at least one of the response time and the cognitive agility of the subject. 17. The bidirectional pressure maintenance device according to claim 13, wherein the subject interactive means analyzes the second information and determines the measurement result of the characteristic of the subject affected by the pressure treatment based on the analysis. 18. The bidirectional pressure maintenance device according to claim 17, wherein the subject interactive means comprises a communication means for communicating at least one of the first information, the second information and the result with the remote storage device. 19. The pressure generating means has a pressure generator for receiving gas from at least one gas supply source and supplying gas to the subject at high pressure, and a first end operatively connected to the pressure generator. 14. The bidirectional pressure maintenance device of claim 13, comprising a respiratory circuit and a subject interface device operatively connected to the second end of the respiratory circuit. 20. The bidirectional pressure maintaining device according to claim 13, wherein the pressure generating device and the bidirectional device are operatively connected to each other in a common housing. 21. At least one bidirectional pressure maintaining device comprising: (a) a pressure generating device for performing pressure treatment on lung tissue of a subject; and (b) a bidirectional device connected to the pressure generating device. The output device includes an output device for supplying the first information to the subject, an input device for receiving the second information supplied from the subject based on the first information, and a second information from the first information and the input device. A control device for controlling the operation of an output device for displaying a summary of the information of at least one, at least one remote storage device in communication with the at least one bidirectional pressure maintenance device, and each at least one bidirectional pressure maintenance device and remote storage device. And a communication device that transmits information in at least one direction between the communication network and the communication network. 22. A process of preparing a pressure generator for performing pressure treatment on a subject, a process of providing first information to the subject by the pressure generator, and a second process from the subject through the pressure generator based on the first information. A method for treating respiratory disorders, comprising: 23. The method of claim 22, wherein the first information includes a test result that measures the effect of pressure therapy. 24. The method of claim 23, wherein the test is a series of questions that measures a subject's daytime sleep propensity. 25. The method of claim 23, wherein the test measures at least one of response time and cognitive agility of the subject. 26. The method of claim 22, including the step of analyzing the second information and the step of analytically determining a measurement of a characteristic of the subject affected by the pressure treatment. 27. The method of claim 26 including the step of storing at least one of the second information and the result. 28. The method of claim 27, further comprising the step of communicating the first information, the second information and / or the result with a remote storage device. 29. The method of claim 22, including the step of collecting third information related to at least one of the first information and the second information. 30. The third information is (1) (a) an inspection management time indicating the time when the first information is provided to the user, and (b) an inspection indicating the time when the second information is received from the user. 30. The method according to claim 29, comprising at least one of time information identifying at least one of the end times and (2) identifying information identifying the first information provided to the user.